Comparative Analysis of Nemonoxacin and Other Anti-methicillin Resistant Staphylococcus Aureus (Anti-MRSA) Antimicrobial Therapy in Patients With Complicated Skin and Soft Tissue Infections (cSSTI): a Retrospective Chart Review Study

April 28, 2025 updated by: National Taiwan University Clinical Trial Center, National Taiwan University Hospital

Increasing rates of antimicrobial resistant bacterial infections and antimicrobial therapy at home in elderly are great concern for medical care. The availability of new antibacterial agents that are effective against bacteria with resistance to other antibacterials is therefore critical to continued successful management of bacterial illnesses in the future. Nemonoxacin is a C-8 methoxy, non-fluorinated quinolone that retains potent broad-spectrum activities against Gram-positive and Gram-negative bacteria by selective inhibition of bacterial DNA topoisomerase.

Nemonoxacin had greater in-vitro activity against many Gram-positive bacteria, including methicillin-susceptible S. aureus (MSSA), and ciprofloxacin-susceptible and ciprofloxacin-resistant MRSA, levofloxacin-susceptible and levofloxacin-resistant S. pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, enterococci, and Enterobacterieacea species except Pseudomonas aeruginosa. Lowe selected mutation of Nemonoxacin, compared with other fluoroquinolones against antimicrobial resistant gram-positive bacteria had been reported.[5] Nemonoxacin could be used once-daily oral and intravenous formulations for the treatment of community-acquired pneumonia, including methicillin resistant Staphylococcus aureus (MRSA). However, nemonoxacin has less evidence of efficacy for complicated skin and soft tissue infection. In this retrospective study, we will investigate the treatment outcomes of nemonoxacin and compared with other anti-methicillin resistant Staphylococcus aureus (anti-MRSA) antimicrobial therapy in patients with complicated skin and soft tissue infections (cSSTI) by chart review.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

144

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

complicated skin and soft tissue (cSSTI) infection

Description

Inclusion Criteria:

  • complicated skin and soft tissue (cSSTI) infection

Exclusion Criteria:

  • no complicated skin and soft tissue (cSSTI) infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Use other antimicrobial therapy (vancomycin, teicoplanin, daptomycin, linezolid, or other anti-MRSA
Use other antimicrobial therapy (vancomycin, teicoplanin, daptomycin, linezolid, or other anti-MRSA antibiotics)
Use Nemonoxacin
Other: Observational study, no intervention
Observational study, no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess the clinical outcome of intravenous/oral nemonoxacin therapy compared with other antimicrobial therapy (vancomycin, teicoplanin, daptomycin, linezolid, or other anti-MRSA antibiotics) in patients with cSSTI.
Time Frame: between 01 January 2023 and 31 January 2025
between 01 January 2023 and 31 January 2025

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2025

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

April 28, 2025

First Submitted That Met QC Criteria

April 28, 2025

First Posted (Estimated)

May 6, 2025

Study Record Updates

Last Update Posted (Estimated)

May 6, 2025

Last Update Submitted That Met QC Criteria

April 28, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202502099RIND

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

To compare the clinical efficacy, antimicrobial efficacy, and adverse drug reactions of nemonoxacin in the treatment of complicated skin and soft tissue infections (cSSTIs) with other anti-MRSA antimicrobial therapies in patients with complicated skin and soft tissue infections.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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